Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four new guidance documents were posted to the tracker since its last update.
Forty-four new guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight's Guidance Tracker in the last two months (from Oct. 12 to Nov. 30).
The US FDA issued 12 guidelines since the last update, including a final document explaining when to submit a 510(k) for a software change to an existing device. While the guideline is helpful, an industry expert believes it does not do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight. (Also see "Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied" - Medtech Insight, 17 Nov, 2017.)
The updated list also includes a draft guideline from the Saudi Food and Drug Authority outlining the procedure that local manufacturers and authorized representatives should follow to address field safety notices (FSNs) issued in relation to their devices.
The updated list of new guidance documents is below. The full Medtech Guidance Tracker is online.
Key:
WHO: World Health Organization
HC: Health Canada
EMA: European Medicines Agency
NBOG: Notified Body Operations Group
HPRA: Health Products Regulatory Authority
MDA: Medical Device Authority
FDA Philippines: Food and Drug Administration Philippines
Saudi FDA: Saudi Food & Drug Authority
HSA: Health Sciences Authority
MCC: Medicines Control Council
Swissmedic: Swiss Agency for Therapeutic Products
MHRA: Medicines and Healthcare products Regulatory Agency
FDA: Food and Drug Administration
Medtech Insight: global medical technology news & analysis
07 May 2021
Bone Health Technologies appoints three new board members following $2.5m funding round, and Nanox Imaging appoints new chief business officer...
Medtech Insight: global medical technology news & analysis
By Marion Webb 07 May 2021
Lilly announced it signed strategic international agreements with four diabetes companies to advance connected solutions and streamline care for people...
Medtech Insight: global medical technology news & analysis
By Amanda Maxwell 07 May 2021
Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU...
Request a Trial
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
How can we help you?
Our team is always happy to hear from you. Please call us at:
Pharma Report Store
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now:
In the continually evolving medtech competitive landscape, it is vital to stay up-to-date with key events. With Meddevicetracker, you’ll be able to anticipate upcoming filings, research clinical trial dates and data, and access market size information and expert forecasts, all in one place.
Get a window into what the leading players across the biopharma, medtech, and diagnostics industries are thinking, as well as important insight into what your competitors are doing. Build your strategy with In Vivo.
Looking for more products Product Finder
